FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80689–80712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2000
NAVIGUS PEEL AWAY INTRODUCER
K002330 · GWG
Image-Guided Neurologics, Inc.
Neurology · 78d
Cleared Oct 18, 2000
COLLAGEN WOUND DRESSING
K002443 · KGN
Oasis Research, LLC
General & Plastic Surgery · 70d
Cleared Oct 18, 2000
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
K002444 · IYE
Sun Nuclear Corp.
Radiology · 70d
Cleared Oct 18, 2000
SMARTLENS
K002510 · HKX
Odc Ophthalmic Development Co. AG
Ophthalmic · 64d
Cleared Oct 18, 2000
EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
K002534 · DRB
Eupalamus, LLC
Cardiovascular · 63d
Cleared Oct 18, 2000
ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2...
K002686 · CBK
Nellcor Puritan Bennett, Inc.
Anesthesiology · 51d
Cleared Oct 18, 2000
KSEA UNIMAT 12
K002700 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 49d
Cleared Oct 18, 2000
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB...
K002849 · HNO
Surgical Specialties Corp
Ophthalmic · 35d
Cleared Oct 18, 2000
SUREONE INSULIN SYRINGE
K002921 · FMF
Hosuk Co., Ltd.
General Hospital · 29d
Cleared Oct 18, 2000
SOLAR SPO2 MODULE WITH MASIMO SET
K002957 · DQA
General Electric Medical Systems...
Anesthesiology · 26d
Cleared Oct 18, 2000
M2376A DEVICELINK SYSTEM, MODEL M2376A
K002967 · MWI
Agilent Technologies, Inc.
Cardiovascular · 26d
Cleared Oct 18, 2000
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
K003090 · EIA
Midmark Corp.
Dental · 15d
Cleared Oct 17, 2000
INSIGHT 4000 ENDOSCOPE
K000252 · MPA
Insight Instruments Mfg., Inc.
Ophthalmic · 264d
Cleared Oct 17, 2000
PROLITE PULSED LIGHT SYSTEM
K000929 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 209d
Cleared Oct 17, 2000
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS
K002198 · OWB
Fluoro Scan Imaging Systems, Inc.
Radiology · 89d
Cleared Oct 17, 2000
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
K002408 · LPL
Unilens Corp., USA
Ophthalmic · 71d
Cleared Oct 17, 2000
HITACHI ALTAIRE
K002420 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Oct 17, 2000
VISION 9000 PHASED ARRAY TORSO COIL
K002482 · MOS
Usa Instruments, Inc.
Radiology · 64d
Cleared Oct 17, 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 36d
Cleared Oct 17, 2000
XPS NITRO SYSTEM
K002828 · ERL
Xomed, Inc.
Ear, Nose, Throat · 36d
Cleared Oct 17, 2000
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
K002898 · GEI
Curon Medical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 17, 2000
HEADBAND FOR BAHA
K002913 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 29d
Cleared Oct 17, 2000
MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
K002936 · LLZ
Sectra-Imtec AB
Radiology · 26d
Cleared Oct 17, 2000
SMALL STATURE USS
K994121 · MNI
Synthes (Usa)
Orthopedic · 316d